Electroanatomical mapping system

ABSTRACT

Apparatus for use with an electroanatomical mapping system, an elongated needle assembly having a distal energy emitter configured to be detectable by the electroanatomical mapping system, an energy-delivery assembly having at least one sensor configured to receive, at least in part, the distal energy emitter of the elongated needle assembly in such a way that the distal energy emitter and said at least one sensor are movable relative to each other. The apparatus includes a signal-interface assembly. The signal-interface assembly includes a signal-input section configured to be signal connectable to said at least one sensor of the energy-delivery assembly. A signal-output section is configured to be signal connectable to an input section of the electroanatomical mapping system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of and claims the benefit of U.S.patent application Ser. No. 17/920,237, entitled “ELECTROANATOMICALMAPPING SYSTEM WITH VISUALIZATION OF ENERGY-DELIVERY AND ELONGATEDNEEDLE ASSEMBLIES,” and filed Oct. 20, 2022, which is a national stageentry of International Application No. PCT/IB2021/054590, entitled“ELECTROANATOMICAL MAPPING SYSTEM,” filed May 26, 2021, which claims thebenefit of U.S. Provisional Application No. 63/040,052, entitled“ELECTROANATOMICAL MAPPING SYSTEM,” and filed Jun. 17, 2020, which arehereby incorporated by reference in their entireties.

TECHNICAL FIELD

This document relates to the technical field of (and is not limited to):(A) a signal-interface assembly for an electroanatomical mapping system(and/or a method associated therewith); and/or (B) an energy-deliveryassembly having a sensor configured to be interfaced to a signal-inputsection of the signal-interface assembly of an electroanatomical mappingsystem (and/or a method associated therewith); and/or (C) a synergisticcombination of an electroanatomical mapping system, an elongated needleassembly, an energy-delivery assembly and a signal-interface assembly(and/or a method associated therewith).

BACKGROUND

Known medical devices are configured to facilitate a medical procedure,and help healthcare providers diagnose and/or treat medical conditionsof sick patients.

SUMMARY

It will be appreciated that there exists a need to mitigate (at least inpart) at least one problem associated with the existing (known)electroanatomical mapping systems. After much study of, andexperimentation with, existing (known) electroanatomical mappingsystems, an understanding (at least in part) of the problem and itssolution have been identified (at least in part) and are articulated (atleast in part) as follows:

Electroanatomic mapping refers to the acquisition and display (via adisplay device) of electrical information (signals) pertaining to(derived or sensed from) a biological feature of a patient incombination with spatial localization (a visual map) of a biologicalfeature (this is done, preferably, in situ). An electroanatomicalmapping system (EAM system) is configured to provide a display deviceconfigured to show (map out and indicate, preferably in real time ornear real time, in situ) the three-dimensional anatomy of a biologicalfeature (such as the heart, etc.) of the patient.

It is known that electroanatomical mapping systems may utilize magneticsensors and/or electrical impedance sensors for generating anatomicalmaps. Moreover, known transcatheter interventional procedures areutilized for the treatment of a biological feature (such as the leftside of the heart) of the patient. For instance, a known procedure amongthese is the pulmonary vein isolation (PVI) procedure that utilizes anablation catheter by way of selective application (emission) ofradio-frequency energy to a desired portion of the biological feature(such as, a biological wall, etc.). The known PVI procedure may beexecuted (performed) with assistance from an electroanatomical mappingsystem configured to visualize both the left atrium (of the heart) andthe ablation catheter (preferably, this is done simultaneously and insitu). While under visualization (via the display device of theelectroanatomical mapping system), a medical device (which transportsthe ablation catheter) may be maneuvered and/or navigated (preferably insitu) in such a way that the ablation catheter may be maneuvered to adesired biological feature (or a biological site) of the patient; oncethe desired biological site is located (by identification via thedisplay device), and the ablation catheter is suitably positionedproximate to (or in contact with) the desired biological site (asindicated by the display device), radio-frequency ablation may beactivated (via the ablation catheter) for formation of a desired lesionat the desired biological site.

It may be desirable to accomplish a procedure with less time and/or withmore certainty, thereby reducing, at least in part, labor costs,operating room time, etc., associated with executing the procedure.

It may be desirable to provide, for the electroanatomical mappingsystem, a medical sheath assembly (which is steerable within thepatient) configured to improve the procedural workflow of a procedure,such as the known PVI procedure, by allowing a medical device (such as amedical sheath assembly, etc.) to be visualized (in situ) along with anablation device (such as an ablation catheter, etc.) via the displaydevice of the electroanatomical mapping system.

Before an ablation procedure may be carried out, a transseptal puncturemay be required to access the left atrium of the heart. This portion ofthe procedure may be very difficult to be properly, and confidently,visualized using the display device of the electroanatomical mappingsystem.

It may be desirable to provide, to users (such as electrophysiologists),an apparatus configured to enable visualization of a radio-frequencytransseptal puncture needle by the electroanatomical mapping system.

It may be desirable to provide, for a procedure using energy puncturing,a signal switch assembly (an electrical switch box) configured to conveyinformation (such as voltage measurements, etc.) from at least onemedical device (such as, a combination of an ablation catheter and/or amedical sheath assembly) to the electroanatomical mapping system.

For instance, electrophysiologists may rely on a mix of ultrasound, suchas, Intracardiac Echocardiography (ICE) and/or TransesophagealEchocardiography (TEE) and fluoroscopy to perform the transseptalpuncture (preferably, in situ); these types of equipment may be,disadvantageously, very expensive to own, maintain and/or operate.

It may be desirable to perform the transseptal puncture by utilizing theelectroanatomical mapping system. In this manner, the user may,advantageously, receive less (preferably no) or limited x-ray radiationfrom fluoroscopy, which may be a high priority; moreover, significantcapital cost might be avoiding ultrasound technologies altogether.

It may be desirable to provide a steerable sheath assembly with sensors(such as electrodes) using the electroanatomical mapping system. It willbe appreciated that a device may be needed for various sensorcombinations deployed on the medical devices.

It may be desirable to share sensors of a combination of medical devices(such as a sheath assembly, an energy puncture device, etc.) forvisualization of the medical devices via the display device of theelectroanatomical mapping system.

It may be desirable to provide electroanatomic mapping based on theacquisition and display (via a display device) of electrical information(signals) pertaining to (derived or sensed from) a biological feature ofa patient in combination with spatial localization (a visual map) of thebiological feature along with at least one sensor (or two or moresensors) associated with at least one medical assembly such as acatheter (or two or more medical assemblies); this is done, preferably,in situ (during a procedure).

To mitigate, at least in part, at least one problem associated with theexisting technology, there is provided (in accordance with a majoraspect) an apparatus. The apparatus is for use with an electroanatomicalmapping system, an elongated needle assembly (having a distal energyemitter configured to be detectable by the electroanatomical mappingsystem), an energy-delivery assembly (having at least one sensorconfigured to receive, at least in part, the distal energy emitter ofthe elongated needle assembly; this is done in such a way that thedistal energy emitter and the sensor are movable relative to eachother). The apparatus includes and is not limited to a signal-interfaceassembly including a signal-input section. The signal-input section isconfigured to be signal connectable to the sensor of the energy-deliveryassembly. The signal-interface assembly also includes a signal-outputsection configured to be signal connectable to an input section of theelectroanatomical mapping system. The electroanatomical mapping systemis configured to display, via a display device, a spatial positioning ofthe sensor of the energy-delivery assembly along with the distal energyemitter (of the elongated needle assembly); this is done, preferably,after: (A) the signal-input section, in use, is signal connected to thesensor of the energy-delivery assembly; and (B) the signal-outputsection, in use, is signal connected to the input section of theelectroanatomical mapping system.

To mitigate, at least in part, at least one problem associated with theexisting technology, there is provided (in accordance with a majoraspect) an apparatus. The apparatus is for use with an electroanatomicalmapping system (including a signal-interface assembly), and is also foruse with an elongated needle assembly (having a distal energy emitterconfigured to be detectable by the electroanatomical mapping system).The apparatus includes and is not limited to an energy-delivery assemblyhaving at least one sensor configured to receive, at least in part, thedistal energy emitter of the elongated needle assembly; this is done insuch a way that the distal energy emitter and the sensor are movablerelative to each other. The sensor is also configured to be interfacedto a signal-input section of the signal-interface assembly. Theelectroanatomical mapping system is configured to display, via a displaydevice, spatial positioning of the sensor of the energy-deliveryassembly along with the distal energy emitter of the elongated needleassembly; this is done, preferably, after: (A) the signal-interfaceassembly, in use, is signal connected to said at least one sensor of theenergy-delivery assembly; and (B) the signal-interface assembly, in use,is signal connected to the input section of the electroanatomicalmapping system.

To mitigate, at least in part, at least one problem associated with theexisting technology, there is provided (in accordance with a majoraspect) a method. The method is for operating an electroanatomicalmapping system (having a signal-interface assembly), an elongated needleassembly (having a distal energy emitter configured to be detectable bythe electroanatomical mapping system), an energy-delivery assembly(having at least one sensor configured to receive, at least in part, thedistal energy emitter of the elongated needle assembly; this is done insuch a way that the distal energy emitter and the sensor are movablerelative to each other). The method includes displaying, via a displaydevice of the electroanatomical mapping system, spatial positioning ofthe sensor of the energy-delivery assembly along with the distal energyemitter (of the elongated needle assembly); this is done, preferably,after: (A) the signal-input section, in use, is signal connected to thesensor of the energy-delivery assembly; and (B) the signal-outputsection, in use, is signal connected to the input section of theelectroanatomical mapping system.

Other aspects are identified in the claims. Other aspects and featuresof the non-limiting embodiments may now become apparent to those skilledin the art upon review of the following detailed description of thenon-limiting embodiments with the accompanying drawings. This Summary isprovided to introduce concepts in simplified form that are furtherdescribed below in the Detailed Description. This Summary is notintended to identify potentially key features or possible essentialfeatures of the disclosed subject matter, and is not intended todescribe each disclosed embodiment or every implementation of thedisclosed subject matter. Many other novel advantages, features, andrelationships will become apparent as this description proceeds. Thefigures and the description that follow more particularly exemplifyillustrative embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The non-limiting embodiments may be more fully appreciated by referenceto the following detailed description of the non-limiting embodimentswhen taken in conjunction with the accompanying drawings, in which:

FIG. 1 depicts a schematic view of an embodiment of a signal-interfaceassembly of an electroanatomical mapping system; and

FIG. 2 and FIG. 3 depict schematic views of embodiments of a displaydevice of the electroanatomical mapping system of FIG. 1 ; and

FIG. 4 depicts a schematic view of an embodiment of the signal-interfaceassembly of the electroanatomical mapping system of FIG. 1 ; and

FIG. 5 depicts a schematic view of an embodiment of a configuration ofthe signal-interface assembly of FIG. 4 ; and

FIG. 6 depicts a schematic view of an embodiment of the signal-interfaceassembly of the electroanatomical mapping system of FIG. 1 ; and

FIG. 7 depicts a schematic view of an embodiment of an energy-deliveryassembly for use with the signal-interface assembly of theelectroanatomical mapping system of FIG. 1 ; and

FIG. 8 depicts a schematic view of an embodiment of the signal-interfaceassembly of the electroanatomical mapping system of FIG. 1 ; and

FIG. 9 depicts a schematic view of an embodiment of a configuration ofthe signal-interface assembly of FIG. 6 and/or FIG. 8 .

The drawings are not necessarily to scale and may be illustrated byphantom lines, diagrammatic representations and fragmentary views. Incertain instances, details unnecessary for an understanding of theembodiments (and/or details that render other details difficult toperceive) may have been omitted. Corresponding reference charactersindicate corresponding components throughout the several figures of thedrawings. Elements in the several figures are illustrated for simplicityand clarity and have not been drawn to scale. The dimensions of some ofthe elements in the figures may be emphasized relative to other elementsfor facilitating an understanding of the various disclosed embodiments.In addition, common, and well-understood, elements that are useful incommercially feasible embodiments are often not depicted to provide aless obstructed view of the embodiments of the present disclosure.

DETAILED DESCRIPTION OF THE NON-LIMITING EMBODIMENT(S)

The following detailed description is merely exemplary and is notintended to limit the described embodiments or the application and usesof the described embodiments. As used, the word “exemplary” or“illustrative” means “serving as an example, instance, or illustration.”Any implementation described as “exemplary” or “illustrative” is notnecessarily to be construed as preferred or advantageous over otherimplementations. All of the implementations described below areexemplary implementations provided to enable persons skilled in the artto make or use the embodiments of the disclosure and are not intended tolimit the scope of the disclosure. The scope of the disclosure isdefined by the claims. For the description, the terms “upper,” “lower,”“left,” “rear,” “right,” “front,” “vertical,” “horizontal,” andderivatives thereof shall relate to the examples as oriented in thedrawings. There is no intention to be bound by any expressed or impliedtheory in the preceding Technical Field, Background, Summary or thefollowing detailed description. It is also to be understood that thedevices and processes illustrated in the attached drawings, anddescribed in the following specification, are exemplary embodiments(examples), aspects and/or concepts defined in the appended claims.Hence, dimensions and other physical characteristics relating to theembodiments disclosed are not to be considered as limiting, unless theclaims expressly state otherwise. It is understood that the phrase “atleast one” is equivalent to “a”. The aspects (examples, alterations,modifications, options, variations, embodiments and any equivalentthereof) are described regarding the drawings. It should be understoodthat the disclosure is limited to the subject matter provided by theclaims, and that the disclosure is not limited to the particular aspectsdepicted and described. It will be appreciated that the scope of themeaning of a device configured to be coupled to an item (that is, to beconnected to, to interact with the item, etc.) is to be interpreted asthe device being configured to be coupled to the item, either directlyor indirectly. Therefore, “configured to” may include the meaning“either directly or indirectly” unless specifically stated otherwise.

FIG. 1 depicts a schematic view of an embodiment of a signal-interfaceassembly 901 of an electroanatomical mapping system 900.

Referring to the embodiment as depicted in FIG. 1 , an energy-deliveryassembly 201 includes a distal energy emitter 208. The energy-deliveryassembly 201 is configured to be inserted into, and movable along, aconfined space defined by a living body (the patient). Movement of theenergy-delivery assembly 201 is to be controlled by a user (by suchmeans as a steering device, etc., not depicted but are known to personsof skill in the art and therefore not described). The energy-deliveryassembly 201 is configured to maneuver, and position, the distal energyemitter 208 proximate to the biological feature of the patient. Theenergy-delivery assembly 201 is configured to maneuver and position thedistal energy emitter 208 along a travel path 209. The distal energyemitter 208 is configured to selectively emit energy (once activated forthe formation of a puncture through a biological feature of the patient)after the energy-delivery assembly 201 has positioned the distal energyemitter 208 proximate to the biological feature of the patient. Thedistal energy emitter 208 is configured to form a puncture onceactivated to emit energy therefrom, such as radio-frequency energy,etc., and any equivalent thereof. The distal energy emitter 208 mayinclude any type of energy-emitting device, etc.

Referring to the embodiment as depicted in FIG. 1 , an energy-deliveryassembly 201 includes biocompatible material properties suitable forsufficient performance (dielectric strength, thermal performance,insulation and corrosion, water and/or heat resistance, etc.) to complywith industrial and/or regulatory safety standards (or compatible formedical usage in general). Reference is made to the followingpublication for consideration in the selection of a suitable material:Plastics in Medical Devices: Properties, Requirements, and Applications;2nd Edition; author: Vinny R. Sastri; hardcover ISBN: 9781455732012;published: 21 Nov. 2013; publisher: Amsterdam[Pays-Bas]:Elsevier/William Andrew, [2014].

Referring to the embodiment as depicted in FIG. 1 , the energy-deliveryassembly 201 includes (and is not limited to) a synergistic combinationof an elongated needle assembly 206, a medical sheath assembly 202, anda medical dilator assembly 204. The elongated needle assembly 206 isconfigured to be received within, and along, an elongated dilator lumenof (defined by) the medical dilator assembly 204. The medical dilatorassembly 204 is configured to be received (at least in part), within andalong, the lumen of the medical sheath assembly 202. The elongatedneedle assembly 206 extends from the distal energy emitter 208. Themedical sheath assembly 202 has at least one sheath sensor mountedthereto (such as, spaced-apart sheath sensors 203A, 203B, 203C, 203D,etc.) and positioned along predetermined spaced-apart positions locatedalong an elongated length of the medical sheath assembly 202. Themedical dilator assembly 204 has at least one dilator sensor (205)positioned (preferably) at the distal end of the medical dilatorassembly 204. A wire 210 is electrically connected to the distal energyemitter 208. The wire 210 extends along a longitudinal length of theelongated needle assembly 206 (from the distal end to the proximal endthereof). A set of sensor wires 216 is electrically connected torespective (one for each of the) sheath sensors (203A, 203B, 203C, 203D)and to the dilator sensor 205.

Referring to the embodiment as depicted in FIG. 1 , the wire 210 extendsalong a length of the energy-delivery assembly 201 (preferably along theinterior thereof) between a proximal end and a distal end of theenergy-delivery assembly 201. At the distal end of the energy-deliveryassembly 201, the wire 210 is electrically connected to the distalenergy emitter 208. At the proximal end of the energy-delivery assembly201, the wire 210 is configured to be electrically connectable to anenergy generator 214 (via a connection 212). The energy generator 214 isconfigured to selectively generate, and output, energy (such asradio-frequency energy) that is conveyed to the distal energy emitter208 (via the wire 210 and the connection 212, etc.). The energygenerator 214 may include a radio frequency-energy generator, etc., andany equivalent thereof.

Referring to the embodiment as depicted in FIG. 1 , the energy-deliveryassembly 201 and the distal energy emitter 208 may, for instance,include (and are not limited to) a radio frequency puncture device, suchas the BAYLIS (TRADEMARK) POWERWIRE (REGISTERED TRADEMARK) radiofrequency guidewire manufactured by BAYLIS MEDICAL COMPANY(headquartered in Canada).

Referring to the embodiment as depicted in FIG. 1 , theelectroanatomical mapping system 900 may include fluoroscopy mappingsystems (if so desired, but may not be preferred for some embodiments).The electroanatomical mapping system 900 includes, preferably, anonfluoroscopy mapping system, such as, and not limited to, (A) theCARTO EP (TRADEMARK) mapping system (manufactured by BIOSENSE WEBSTERbased in the USA), (B) the ENSITE PRECISION (TRADEMARK) cardiac mappingsystem (manufactured by Abbott Laboratories based in the USA), (C) theLOCALISA (TRADEMARK) intracardiac mapping system (manufactured byMEDTRONICS INC., based in the USA), and (D) the RHYTHMIA HDx (TRADEMARK)mapping system (manufactured by Boston Scientific Corp., based in theUSA).

Referring to the embodiment as depicted in FIG. 1 , the signal-interfaceassembly 901 is configured to be electrically connectable (via a wireand/or wirelessly, directly or indirectly, etc.) to theelectroanatomical mapping system 900. The signal-interface assembly 901may include, for instance, a pin box, a housing having an array ofreceivers (sockets) configured to receive plugs (wired plugs), etc., andany equivalent thereof. The signal-interface assembly 901 may beconfigured for conveying any type of signal, such as an electro-magneticsignal, an electrical signal and/or a magnetic signal, etc., and anyequivalent thereof. The signal-interface assembly 901 is configured toreceive signals from the sensors (203A, 203B, 203C, 203D, 205) of theenergy-delivery assembly 201. In addition, the signal-interface assembly901 is configured to receive (at least in part) the signal from theenergy generator 214 (which may be the same or a similar energy signalprovided to the distal energy emitter 208 of the energy-deliveryassembly 201). The distal energy emitter 208 is configured to beactivated. The sheath sensors (203A, 203B, 203C, 203D) and the dilatorsensor 205 (and the activated distal energy emitter 208) are allconfigured to be detectable by the electroanatomical mapping system 900(via the signal-interface assembly 901 and/or by other types of sensingdevices, not depicted and known to persons skilled in the art, such asmagnetic devices and/or electrical impedance devices, etc., and anyequivalent thereof).

Referring to the embodiment as depicted in FIG. 1 , the display device902 is configured to be electrically connected to the electroanatomicalmapping system 900. The electroanatomical mapping system 900 isconfigured to output (in use) mapping information (visual representationdata) to the display device 902, in which the mapping information mayinclude relative spatial positions of the distal energy emitter 208(once activated), the sheath sensors (203A, 203B, 203C, 203D) and thedilator sensor 205, during a procedure (in situ). In this arrangement,the user is provided with additional visual information (of medicaldevices inserted into the patient) so that the user may make improved(or better) procedural decisions during the procedure.

Referring to the embodiment as depicted in FIG. 1 , the energy-deliveryassembly 201 is configured to be enabled for use with theelectroanatomical mapping system 900. The energy-delivery assembly 201and the electroanatomical mapping system 900 may be utilized for anytype of procedure, such as the transseptal puncture procedure portion ofa procedure. The technical effect of the energy-delivery assembly 201and/or the signal-interface assembly 901 is provision of improved(expanded) visualization of the medical devices inserted in the body ofthe patient (such as the energy-delivery assembly 201) during aprocedure. The energy-delivery assembly 201 includes sensors configuredto be detected by the electroanatomical mapping system 900; this is donein such a way that the electroanatomical mapping system 900 may providea visual map (mapping data) to the display device 902 (based on sensordata received by the signal-interface assembly 901). For instance, theenergy-delivery assembly 201 may provide a tool for locating the ideallocation on a biological feature (such as, the septum and/or the foramenovale), aligning a puncture angle, and confirming contact with, and/orthe tenting of, a biological wall before application of energy to thetissue via the distal energy emitter 208. The physician (user) may beable to see (visualize) the energy-delivery assembly 201 via the displaydevice 902, preferably as in-line, coaxial catheters, much as they mightappear to the eye of the user, as depicted in FIG. 2 and FIG. 3 .

Referring to the embodiment as depicted in FIG. 1 , there is depicted anapparatus for use with the electroanatomical mapping system 900, theelongated needle assembly 206 (having the distal energy emitter 208configured to be detectable by the electroanatomical mapping system900), and the energy-delivery assembly 201 (having at least one sensorconfigured to receive, at least in part, the distal energy emitter 208of the elongated needle assembly 206; this is done in such a way thatthe distal energy emitter 208 and the sensor are movable relative toeach other). The apparatus includes and is not limited to (comprises) asignal-interface assembly 901. The signal-interface assembly 901includes a signal-input section 910 configured to be signal connectableto the sensor of the energy-delivery assembly 201. The signal-interfaceassembly 901 also includes a signal-output section 912 configured to besignal connectable to an input section of the electroanatomical mappingsystem 900. The electroanatomical mapping system 900 is configured todisplay, via the display device 902, spatial positions of the sensor ofthe energy-delivery assembly 201 along with the distal energy emitter208 of the elongated needle assembly 206; this is done, preferably,after: (A) the signal-input section 910, in use, is signal connected tothe sensor of the energy-delivery assembly 201; and (B) thesignal-output section 912, in use, is signal connected to the inputsection of the electroanatomical mapping system 900.

Referring to the embodiment as depicted in FIG. 1 , there is depicted anapparatus for use with the electroanatomical mapping system 900(including the signal-interface assembly 901). The apparatus is also foruse with the elongated needle assembly 206 (having the distal energyemitter 208 configured to be detectable by the electroanatomical mappingsystem 900). The apparatus includes and is not limited to (comprises)the energy-delivery assembly 201 having at least one sensor configuredto receive, at least in part, the distal energy emitter 208 of theelongated needle assembly 206 (this is done in such a way that thedistal energy emitter 208 and the sensor are movable relative to eachother). The sensor is also configured to be interfaced to a signal-inputsection 910 of the signal-interface assembly 901. The electroanatomicalmapping system 900 is configured to display, via a display device,spatial positions of the sensor of the energy-delivery assembly 201along with the distal energy emitter 208 (of the elongated needleassembly 206); this is done, preferably, after: (A) the signal-interfaceassembly 901, in use, is signal connected to said at least one sensor ofthe energy-delivery assembly 201; and (B) the signal-interface assembly901, in use, is signal connected to the input section of theelectroanatomical mapping system 900.

Referring to the embodiment as depicted in FIG. 1 , there is depicted anapparatus that includes and is not limited to (comprises) a synergisticcombination of the electroanatomical mapping system 900, the elongatedneedle assembly 206, the energy-delivery assembly 201 and thesignal-interface assembly 901.

FIG. 2 and FIG. 3 depict schematic views of embodiments of a displaydevice 902 of the electroanatomical mapping system 900 of FIG. 1 .

Referring to the embodiments as depicted in FIG. 2 and FIG. 3 , thedisplay device 902 provides (in use) the visualization map (also calledmapping information). The visualization map, for instance, indicates:(A) a sheath image 802 of (representing) the medical sheath assembly 202(as depicted in FIG. 1 ); (B) a dilator image 804 of (representing) themedical dilator assembly 204 (as depicted in FIG. 1 ); (C) an elongatedneedle image 806 of (representing) the elongated needle assembly 206 (ofFIG. 1 ); and (D) a puncture-device image 808 of (representing) thedistal energy emitter 208 (of FIG. 1 ).

Referring to the embodiment as depicted in FIG. 2 , the display device902 depicts the mapping information in which the visual representation(as depicted) implies (infers) that the image representing the distalenergy emitter 208 is depicted as being positioned relatively closer to(retracted within) the distal end portion of the image representing theenergy-delivery assembly 201.

Referring to the embodiment as depicted in FIG. 3 , the display device902 depicts the mapping information. The visual imaging representation(as depicted) implies (infers) the distal energy emitter 208 ispositioned relatively further away from (extended away from) the distalend portion of the energy-delivery assembly 201. The distal energyemitter 208 may be visualized as being movable along the travel path 209or movement direction (by referring to the movement of thepuncture-device image 808).

FIG. 4 depicts a schematic view of an embodiment of the signal-interfaceassembly 901 of the electroanatomical mapping system 900 of FIG. 1 .

Referring to the embodiment as depicted in FIG. 4 , there is depicted ahandle assembly 500. It will be appreciated that some of the items (orcomponents) of the handle assembly 500 are known to persons skilled inthe art (such as, a steering device, etc.), and as such, these items arenot described in detail.

Referring to the embodiment as depicted in FIG. 4 , the handle assembly500 includes a sheath steering adjustment knob 502, a handle extension504, a needle handle 506 and a conductor cable 508. The conductor cable508 is configured to convey energy to the distal energy emitter 208(once connected accordingly to the energy generator 214, etc.). Thehandle assembly 500 also includes an extension cable 510 for theconductor cable 508. The handle assembly 500 also includes a switch box512. The switch box 512 is configured to connect (split) the signalsbetween the energy generator 214 to (A) the distal energy emitter 208(via the conductor cable 508, etc.), and (B) the signal-interfaceassembly 901 (via the mapping cable 514). The mapping cable 514 isconfigured to convey the energy signal of the energy generator 214 tothe signal-interface assembly 901.

Referring to the embodiment as depicted in FIG. 4 , the handle assembly500 also includes a sheath side port tube 516. The handle assembly 500also includes a sheath conductor cable 518. The sheath conductor cable518 is configured to convey the signals from the sensors (203A, 203B,203C, 203D, 205) to the signal-interface assembly 901 (via specific orpredetermined conductors, etc.). The sheath conductor cable 518 isconfigured to electrically connect to a mapping cable 520. A hub 522extends from an end section of the mapping cable 520. A dedicatedconductor 524 extends from the hub 522 of the mapping cable 520. Themapping cable 520 is configured to split into multiple conductors each(respectively) having a dedicated pin (703A, 703B, 703C, 703D, 705) alsocalled plugs, etc. Each of the pins (703A, 703B, 703C, 703D, 705) isconfigured to be inserted into a respective dedicated socket (portal,receiver) of the signal-interface assembly 901. The pins (703A, 703B,703C, 703D, 705) are configured to be electrically respectivelyconnectable to a dedicated socket of the signal-interface assembly 901,and are configured (respectively) to convey sensor signals from thesensors (203A, 203B, 203C, 203D, 205) to the signal-interface assembly901. The pin 708 is connected to the mapping cable 514. The pin 708 isconfigured to (A) be electrically connectable to a dedicated socket ofthe signal-interface assembly 901, and (B) (respectively) convey (atleast in part) the energy signal from the energy generator 214 to thesignal-interface assembly 901 (which is the energy signal also sent tothe distal energy emitter 208).

Referring to the embodiment as depicted in FIG. 4 , the energy generator214 is configured to be electrically connectable to the distal energyemitter 208 and to the signal-interface assembly 901 via the connection212 and the switch box 512, etc. The signal-interface assembly 901includes an array of sockets 905 configured to be electricallyconnectable to the pins (703A, 703B, 703C, 703D, 705, 708). The pins(703A, 703B, 703C, 703D, 705, 708) are assigned (preferably) intogroupings. The pins (703A, 703B, 703C, 703D) are assigned to a first pingroup so that the signal-interface assembly 901 may convey these signalsto the electroanatomical mapping system 900 to represent signalsassociated with a first aspect of the energy-delivery assembly 201 (suchas, a length of a portion of the medical sheath assembly 202 of theenergy-delivery assembly 201, etc.). The pins (703A, 705) are assignedto a second pin group so that the signal-interface assembly 901 mayconvey these signals to the electroanatomical mapping system 900 torepresent signals associated with a second aspect of the energy-deliveryassembly 201 (such as, the relative separation distance between thedistal tips of the medical sheath assembly 202 and the medical dilatorassembly 204). The pins (705, 708) are assigned to a third pin group sothat the signal-interface assembly 901 may convey these signals to theelectroanatomical mapping system 900 to represent signals associatedwith a third aspect of the energy-delivery assembly 201 (such as, therelative separation distance between the distal tip of the medicaldilator assembly 204 and the distal energy emitter 208 positioned at thedistal end of the elongated needle assembly 206, etc.).

Referring to the embodiment as depicted in FIG. 4 , it will beappreciated that a use of the signal-interface assembly 901 may includethe mapping visualization of the medical sheath assembly 202, themedical dilator assembly 204 and the elongated needle assembly 206 (tobe depicted on the display device 902, during a procedure, such as thetransseptal puncture procedure); it will be appreciated that,preferably, the signal-interface assembly 901 is a way to replace and/orsupplement the use of the intracardiac echo system and/or thefluoroscopy system, etc., if so desired.

Referring to the embodiment as depicted in FIG. 4 , the signal-interfaceassembly 901 is configured to electrically convey (in use) electricalsignals from aspects of the energy-delivery assembly 201 to enablevisualization of at least one aspect (geometrical visual aspect) of theenergy-delivery assembly 201 via the display device 902 of theelectroanatomical mapping system 900. The mapping software of theelectroanatomical mapping system 900 is configured to receive and handlethese signals in order to generate the visualization map to be displayedon the display device 902 (as depicted, for instance, in FIG. 2 and/orFIG. 3 ). The mapping software (programming) of the electroanatomicalmapping system 900 may be configured to visually map out the alignmentof the components of the energy-delivery assembly 201, etc., that may beutilized (by the user) for visually assisting the user during aprocedure. Without using the signal-interface assembly 901, forinstance, visualization of the alignment of the components of theenergy-delivery assembly 201 may be more difficult to achieve (and proneto unwanted errors, etc.). The mapping software of the electroanatomicalmapping system 900 may be configured to compute, and then display viathe display device 902, the alignment of the components of theenergy-delivery assembly 201.

FIG. 5 depicts a schematic view of an embodiment of a configuration ofthe signal-interface assembly 901 of FIG. 4 .

Referring to the embodiment as depicted in FIG. 5 , there is depicted anassignment of groupings for the sockets 905 of the signal-interfaceassembly 901 of FIG. 4 . It will be appreciated that otherconfigurations for, or variations of, the pairing or grouping of pinsand sockets may be realized, as desired, in order to obtain and displaydifferent visual aspects of the energy-delivery assembly 201 (as may beneeded for specific procedures).

FIG. 6 depicts a schematic view of an embodiment of the signal-interfaceassembly 901 of the electroanatomical mapping system 900 of FIG. 1 .

Referring to the embodiment as depicted in FIG. 6 , there is depicted ahandle assembly 600 including a steering adjustment knob 602, a handleextension 604, a needle handle 606, and an energy cable 608 (forconveying energy to the distal energy emitter 208). The handle assembly600 also includes an extension cable 610 for the energy cable 608, etc.

Referring to the embodiment as depicted in FIG. 6 , the handle assembly600 also includes a switch-box assembly 612. The switch-box assembly 612includes an energy port 613 configured to convey the energy signal fromthe connection 212 to the distal energy emitter 208 (via the extensioncable 610, the energy cable 608, etc.).

Referring to the embodiment as depicted in FIG. 6 , the handle assembly600 also includes a sheath side port tube 616, and a sheath wireassembly 618. The sheath wire assembly 618 provides dedicated wires eachrespectively electrically connected to dedicated sensors (203A, 203B,203C, 203D, 205). A sheath extension cable 619 connects to the sheathwire assembly 618 (for extending the sheath wire assembly 618, etc.).

Referring to the embodiment as depicted in FIG. 6 , the switch-boxassembly 612 includes a sensor-signal port 614. The sensor-signal port614 is configured to electrically connect to the sheath wire assembly618 (via the sheath extension cable 619), to a mapping cable 620, etc. Aset of conductors extends from a hub 622 of the mapping cable 620. Aconductor 624 extends from the hub 622. The mapping cable 620 splitsinto pins (703A, 703B, 703C, 703D, 705, 708). The pins (703A, 703B,703C, 703D, 705, 708) are configured to electrically connect torespective sockets of the signal-interface assembly 901, and areconfigured to convey sensor signals of respective sensors (203A, 203B,203C, 203D, 205) and the energy signal (to be applied to the distalenergy emitter 208) from the energy generator 214 to thesignal-interface assembly 901.

Referring to the embodiment as depicted in FIG. 6 , the energy generator214 is connectable to the distal energy emitter 208 via the connection212. Advantageously, additional physical aspects of the energy-deliveryassembly 201 may be visualized by utilizing the embodiment as depictedin FIG. 6 . For instance, the curvature of the energy-delivery assembly201 (or component thereof) may be better visualized (more accurately).

FIG. 7 depicts a schematic view of an embodiment of an energy-deliveryassembly 201 for use with the signal-interface assembly 901 of theelectroanatomical mapping system 900 of FIG. 1 . The view of FIG. 7represents a longitudinal cross-sectional view of a portion of a medicaldilator assembly 204 and a medical sheath assembly 202 (of theenergy-delivery assembly 201).

Referring to the embodiment as depicted in FIG. 7 , the medical sheathassembly 202 includes the handle extension 604. The sheath lumen 211 isdefined through the handle extension 604 (or the medical sheath assembly202). The sheath sensor 203A is positioned proximal to (close to) thedilator sensor 205. The medical dilator assembly 204 is received alongthe sheath lumen 211 of the medical sheath assembly 202. The dilatorsensor 205 is mounted to the distal portion of the medical dilatorassembly 204. The sheath wire assembly 618 exits from the handleextension 604 of the medical sheath assembly 202. The sheath wireassembly 618 provides a bundle of wires (conductors) to be electricallyconnected (either directly or indirectly) to the signal-interfaceassembly 901. The first electrical wire 813A is configured to convey thesensor signal of the sheath sensor 203A of the medical sheath assembly202. The first electrical wire 813A merges with (or is connected to) aspecific conductor of the sheath wire assembly 618. The secondelectrical wire 815 is configured to convey the sensor signal of thedilator sensor 205 of the medical dilator assembly 204.

Referring to the embodiment as depicted in FIG. 7 , an electricalcommutator device 836 is configured to convey the sensor signal of thesecond electrical wire 815 to a specific conductor of the sheath wireassembly 618. The electrical commutator device 836 (such as electricalcommutator rings and contacts, etc., and any equivalent thereof) isconfigured to transfer electrical signals (and/or power) between astationary element (such as the handle extension 604, etc.) and amovable and/or rotating shaft (such as the medical dilator assembly 204,etc.). The electrical commutator device 836 includes (preferably) afirst electrical contact 833 mounted to the handle extension 604. Theelectrical commutator device 836 is configured for connecting the secondelectrical wire 815 to a dedicated wire of the sheath wire assembly 618(via the electrical commutator device 836). The electrical commutatordevice 836 includes (preferably) a second electrical contact 835 mountedto the medical dilator assembly 204. The second electrical contact 835is configured for the second electrical wire 815 (via the firstelectrical contact 833). The first electrical contact 833 and the secondelectrical contact 835 are configured to electrically contact each otherwhile permitting relative movement between the medical dilator assembly204 and the medical sheath assembly 202. It will be appreciated that analternate embodiment (not depicted) provides an arrangement for aseparate cable (wire) added for the dilator sensor 205, without theelectrical commutator device 836.

FIG. 8 depicts a schematic view of an embodiment of the signal-interfaceassembly 901 of the electroanatomical mapping system 900 of FIG. 1 .

Referring to the embodiment as depicted in FIG. 8 , there is provided afirst internal jumper 1002 and a second internal jumper 1004. Theinternal jumpers (connections) are configured to transmit the dilatorelectrode signal from the dilator sensor 205 to the sheath wire assembly618 (or to a sheath conductor cable 518, as depicted in FIG. 4 ). Itwill be appreciated that an alternate embodiment (not depicted) may beto provide a separate cable for the dilator sensor 205, etc.

Referring to the embodiment as depicted in FIG. 8 , another arrangementto couple the sensors of the energy-delivery assembly 201 in thevisualization on the mapping system is by using software (deployed onthe electroanatomical mapping system 900). Since the mapping systemsoftware (of the electroanatomical mapping system 900) is configured tocreate (generate) the visualization (mapping information), the softwaremay force the visualization map to be displayed to indicate improvedcoaxial alignment of the elements of the energy-delivery assembly 201,provided the software is programmed to identify the components of theenergy-delivery assembly 201 (such as, dilator and sheath, etc.) and areconnected in a specific physical manner or arrangement.

Referring to the embodiment as depicted in FIG. 8 , it will beappreciated that assignment of the sensors of the energy-deliveryassembly 201 (such as the dilator and sheath, etc.) may be accomplishedseparately in the mapping system software with shared sensors to modelseparate visualizations with different diameters, colours, etc., and/ora precisely aligned connection, such that the components of theenergy-delivery assembly 201 may be displayed coaxially.

Referring to the embodiment as depicted in FIG. 8 , it will beappreciated that visualization information of the elongated needleassembly 206, the medical dilator assembly 204 and/or the medical sheathassembly 202 in the visualization map (to be displayed in the displaydevice 902) may be accomplished by way of the signal-interface assembly901 (an intermediate platform) for combining the electrical connections.

Referring to the embodiment as depicted in FIG. 8 , it will beappreciated that many other configurations may be possible for dedicatedsensor conductors aligned along the energy-delivery assembly 201.

Referring to the embodiment as depicted in FIG. 8 , it will beappreciated that the dilator signal may only be available when thedilator is locked into the hub in order to assure the spacing ofinter-catheter electrodes is fixed.

Referring to the embodiment as depicted in FIG. 8 , it will beappreciated that using multiple shared sensors (electrodes) between thecatheters (the components of the energy-delivery assembly 201) tomaintain a minimum of three electrodes for each individual cathetermodel may capture curvature and better accuracy of the tip vector.

FIG. 9 depicts a schematic view of an embodiment of a configuration ofthe signal-interface assembly 901 of FIG. 6 and/or FIG. 8 .

Referring to the embodiment as depicted in FIG. 9 , there is depicted anassignment between the pins and groupings for the sockets 905 of thesignal-interface assembly 901 of FIG. 6 or of FIG. 8 . It will beappreciated that other configurations for (assignment of) the groupingof pins may be realized, as desired, etc.

The following is offered as further description of the embodiments, inwhich any one or more of any technical feature (described in thedetailed description, the summary and the claims) may be combinable withany other one or more of any technical feature (described in thedetailed description, the summary and the claims). It is understood thateach claim in the claims section is an open ended claim unless statedotherwise. Unless otherwise specified, relational terms used in thesespecifications should be construed to include certain tolerances thatthe person skilled in the art would recognize as providing equivalentfunctionality. By way of example, the term perpendicular is notnecessarily limited to 90.0 degrees, and may include a variation thereofthat the person skilled in the art would recognize as providingequivalent functionality for the purposes described for the relevantmember or element. Terms such as “about” and “substantially”, in thecontext of configuration, relate generally to disposition, location, orconfiguration that are either exact or sufficiently close to thelocation, disposition, or configuration of the relevant element topreserve operability of the element within the disclosure which does notmaterially modify the disclosure. Similarly, unless specifically madeclear from its context, numerical values should be construed to includecertain tolerances that the person skilled in the art would recognize ashaving negligible importance as they do not materially change theoperability of the disclosure. It will be appreciated that thedescription and/or drawings identify and describe embodiments of theapparatus (either explicitly or inherently). The apparatus may includeany suitable combination and/or permutation of the technical features asidentified in the detailed description, as may be required and/ordesired to suit a particular technical purpose and/or technicalfunction. It will be appreciated that, where possible and suitable, anyone or more of the technical features of the apparatus may be combinedwith any other one or more of the technical features of the apparatus(in any combination and/or permutation). It will be appreciated thatpersons skilled in the art would know that the technical features ofeach embodiment may be deployed (where possible) in other embodimentseven if not expressly stated as such above. It will be appreciated thatpersons skilled in the art would know that other options may be possiblefor the configuration of the components of the apparatus to adjust tomanufacturing requirements and still remain within the scope asdescribed in at least one or more of the claims. This writtendescription provides embodiments, including the best mode, and alsoenables the person skilled in the art to make and use the embodiments.The patentable scope may be defined by the claims. The writtendescription and/or drawings may help to understand the scope of theclaims. It is believed that all the crucial aspects of the disclosedsubject matter have been provided in this document. It is understood,for this document, that the word “includes” is equivalent to the word“comprising” in that both words are used to signify an open-endedlisting of assemblies, components, parts, etc. The term “comprising”,which is synonymous with the terms “including,” “containing,” or“characterized by,” is inclusive or open-ended and does not excludeadditional, unrecited elements or method steps. Comprising (comprisedof) is an “open” phrase and allows coverage of technologies that employadditional, unrecited elements. When used in a claim, the word“comprising” is the transitory verb (transitional term) that separatesthe preamble of the claim from the technical features of the disclosure.The foregoing has outlined the non-limiting embodiments (examples). Thedescription is made for particular non-limiting embodiments (examples).It is understood that the non-limiting embodiments are merelyillustrative as examples.

We claim:
 1. An energy delivery assembly for transseptal punctureadapted for use with an electroanatomical mapping system, the assemblycomprising: a medical sheath having a dilator lumen; a medical dilatorconfigured to advance through the dilator lumen of the medical sheath,the medical dilator having a puncture device lumen; an energy puncturedevice having a distal portion including a distal energy emitterconfigured to be detectable by the electroanatomical mapping system, thepuncture device configured to advance through the puncture device lumen;at least one sensor coupled to at least one of the medical sheath andthe medical dilator such that the distal energy emitter and said atleast one sensor are movable relative to each other; and asignal-interface assembly including a signal-input section configured tobe operably coupled to said at least one sensor and a signal-outputsection configured to be operably coupled to an input section of theelectroanatomical mapping system; wherein the electroanatomical mappingsystem is configured to operably couple to the signal-interface assemblyand to display spatial positions of the at least one sensor and thedistal energy emitter.
 2. The assembly of claim 1 wherein theenergy-delivery assembly further includes a wire extending along alength of the puncture device, the wire electrically connected to thedistal energy emitter.
 3. The assembly of claim 1 wherein the medicalsheath has at least one sensor.
 4. The assembly of claim 1 wherein themedical dilator has a least one sensor.
 5. The assembly of claim 4wherein the puncture device is a radio-frequency puncture needle.
 6. Theassembly of claim 1 wherein the signal-interface assembly is configuredto receive at least one sensor signal from the at least one sensor andto convey the least one sensor signal to the electroanatomical mappingsystem.
 7. The assembly of claim 6 wherein the signal-interface assemblyis configured to receive an energy signal associated with theenergy-delivery assembly and convey the energy signal to theelectroanatomical mapping system.
 8. The assembly of claim 1 furthercomprising a display device configured to be electrically connected tothe electroanatomical mapping system.
 9. The assembly of claim 8 whereinthe electroanatomical mapping system is configured to output mappinginformation to the display device, the mapping information includes aspatial position of the distal energy emitter and the at least onesensor.
 10. The assembly of claim 1 further comprising a mapping cableconfigured to split into multiple conductors each having at least onededicated pin electrically connected to at least one sensor, the mappingcable also configured to interface with the signal-interface assembly.11. The assembly of claim 1 wherein the signal-interface assembly isconfigured to convey electrical signals from an aspect of theenergy-delivery assembly to enable visualization of aspects of theenergy-delivery assembly via a display device of the electroanatomicalmapping system.
 12. The assembly of claim 1 wherein the at least onesensor includes a dilator sensor coupled to the medical dilator and asheath sensor coupled to the medical sheath.
 13. The assembly of claim12 wherein the medical sheath is steerable and includes a handle havinga steering adjustment knob.
 14. The assembly of claim 13 wherein thehandle includes a conductor cable adapted to operably couple with thesignal-interface assembly.